Kornimate/medical-research-clean huggingface dataset:
closed loop spinal cord stimulation for chemotherapy induced peripheral neuropathy, a pilot study.

Conditions: Peripheral Neuropathy Due to Chemotherapy

Summary: to explore the benefits of using closed loop spinal cord stimulation (scs) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (cipn) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.

primary objective: to explore the impact of using closed loop spinal cord stimulation (scs) on pain control, quality of life, and pain medication use in patients suffering from chemotherapy induced peripheral neuropathy (cipn). secondary objective: to assess the relationship between pain control from closed loop spinal cord stimulation and any associated changes in quantitative sensory testing (qst) and quantitative gait testing (qgt).

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis history of cipn of lower extremities * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of scs * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients undergoing active chemotherapy or immunotherapy * patients undergoing medical litigation. * patients with active infection, being treated with antibiotics * patients that are pregnant or planning to conceive * patients who are receiving any investigational agents. * patients with brain metastases. * patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements. * patients with history of alternative forms of sensorimotor neuropathies prior to cipn presentation
suv on 68ga-dotatate pet/ct and ki-67 index in neuro-endocrine tumors

Conditions: Neuroendocrine Tumors

Summary: positron emission tomography/computed tomography (pet/ct) is an advanced nuclear medicine scan. this technology allows precise and early cancer to be visualized and measured on whole body images. patients with neuro-endocrine tumors (nets), require specialized molecular imaging to stage, re-stage and assess eligibility and response to therapy. 68ga-dotatate is a nuclear medicine imaging agent that is not yet approved by health canada but used extensively throughout the world. the ki-67 index, a marker of cell proliferation in nets, is one of the most important prognostic factors in this disease. the objective of this study is to evaluate if the maximal standard uptake value (suvmax) on pet/ct in nets inversely correlates with ki-67 score on initial biopsy. if this hypothesized correlation between suv and ki-67 score is reproduced, then dotatate would serve as a non-invasive method to assess cellular proliferation and therefore prognosis of these patients.


Eligibility criteria:
inclusion criteria: * known or suspected somatostatin receptor positive tumor such as: neuroendocrine tumor (carcinoid, gastro-entero-pancreatic neuroendocrine tumors, etc); pheochromocytoma; neuroblastoma; medulloblastoma; ectopic cushing syndrome/non-pituitary acth elevation; tumor-induced osteomalacia. supporting evidence may include mri, ct, biochemical markers, and/or pathology report. * previous diagnosis of net with ki-67 index available or soon to be obtained. * ecog performance status 0 - 3, inclusive. * 18 years or older and able to understand and provide written informed consent * patients must be able to tolerate the physical/logistical requirements of a pet/ct scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug exclusion criteria: * medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * patients who exceed the safe weight limit or bore of the pet/ct bed * patients who are claustrophobic or pregnant

Keywords: 68ga-dota-tate, pet/ct
4scar-cd44v6 t cell therapy targeting cancer

Conditions: Cancers Which Are CD44v6 Positive

Summary: the purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4scar-cd44v6 t-cell therapy targeting multiple cancers. the study also aims to learn more about the function of the cd44v6 car-t cells and their persistency in the patients.

cd44 variant domain 6 (cd44v6) which belongs to cd44 family has been implicated in tumorigenesis, tumor cell invasion and metastasis. the expression of cd44v6 was reported for the majority of squamous cell carcinomas, a proportion of adenocarcinomas of differing origin, a proportion of melanoma and lymphoma. this expression pattern has made cd44v6 an attractive target for the therapy of various types of cd44v6 positive cancers. the t cells from patients or transplantation donors will be genetically modified with lentiviral car vector to recognize specific molecules - cd44v6 expressed on the surface of the cancer cells. the engineered t cells will be applied to patients through intravenous delivery. the purpose of this clinical trial is to assess the feasibility, safety and efficacy of cd44v6 car-t cell therapy in multiple cancers including - but not limited to - stomach cancer, breast cancer, prostate cancer, multiple myeloma and lymphoma which are cd44v6 positive. another goal of the study is to learn more about the function of the 4scar-cd44v6 t cells and their persistency in the patients.

Eligibility criteria:
inclusion criteria: 1. age older than 6 months. 2. confirmed expression of cd44v6 in tumor specimens by immuno-histochemical staining or flow cytometry. 3. karnofsky performance status (kps) score is higher than 70 and life expectancy \> 3 months. 4. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dl. 5. hgb≥80g/l. 6. no cell separation contraindications. 7. abilities to understand and the willingness to provide written informed consent. exclusion criteria: 1. sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. active bacterial, fungal or viral infection not controlled by adequate treatment. 3. known hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. 4. pregnant or nursing women may not participate. 5. use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. receive treatment related to cd44v6 targeted therapy. 7. patients, in the opinion of investigators, may not be able to comply with the study.

Keywords: car-t cd44v6 breast cancer gastric cancer lymphoma
efficacy of the additional mechanical pleurodesis for surgical management of primary spontaneous pneumothorax

Conditions: Primary Spontaneous Pneumothorax

Summary: for the definite treatment of primary spontaneous pneumothorax(psp), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. but additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. according to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. the purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of psp.


Eligibility criteria:
inclusion criteria: * recurrent pneumothorax * bilateral pneumothorax * total collapse/tension pneumothorax * previous history of contralateral pneumothorax * visible bulla on simple x-ray * special occupation/situation * air leakage more than 2 days with drainage catheter for 1st attack patients exclusion criteria: * patient refusal and reoperation case

Keywords: pneumothorax, thoracoscopy, pleurodesis
standard comprehensive intervention to treat first-episode schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is not a curable but a treatable disease by antipsychotics. kinds of atypical antipsychotics are widely used since 1990s' in china. although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. and those patients also need more comprehensive intervention such as psychosocial programs to improve their function. this protocol is to conduct a study in several sites of china to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. in addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.


Eligibility criteria:
inclusion criteria: * schizophrenic patients diagnosed with dsm-iv criteria by scid-i. * age between 16-45 years old * with disease course less than 3 years and during their first episode * without receiving systematic antipsychotic treatment less than 1 month exclusion criteria: * organic disease or unstable physical diseases. * brain trauma with loss of consciousness more than 1 hour * current substance misuse (in 3 months) or any substance dependence. * pregnant women. * patients with severe suicidal imaginations or behavior. * mental retardation * contradict to the study drugs

Keywords: schizophrenia first episode atypical antipsychotics psychosocial intervention outcome effectiveness
sleep, nutrition and psychological functioning in kindergarten children

Conditions: Prevention Harmful Effects

Summary: the proposed study has the following aims: (a) to assess the concomitant and longitudinal links between sleep and cognitive, behavioral and emotional functioning in kindergarten children; (b) to assess the immediate and the long-term effects of an intervention to promote healthy sleep habits (hsi) on the child's evolving sleep patterns, as well as on related cognitive, behavioral and health domains; (c) to assess the immediate and the long-term effects of an intervention deigned to promote healthy nutrition (hni) on the eating habits of children, their weight and bmi measures (the comparison/control group) and (d) to assess the links between eating habits and sleep in kindergarten children. the main hypotheses of the proposed study are: (a) shorter and more disrupted sleep would be concomitantly and longitudinally associated with compromised cognitive, emotional and behavioral functioning in kindergarten children; (b) in comparison to the hni group, children in the hsi group will extend their total sleep time, improve their sleep quality and their sleep schedule will be more stable following the intervention; (c) improvement in sleep habits will be associated with improvement in cognitive, emotional and behavioral functioning; (d) in comparison to the his group, children in the hni group will improve their eating habits, engage in more physical activities and better manage to achieve and maintain an age-appropriate body weight.


Eligibility criteria:
inclusion criteria: * preschool children (aged 3-6 years) and their parents exclusion criteria: * (a) significant health or neurological-developmental problems; (b) severe psychological problems, psychiatric diagnosis or treatment; (c) concurrent psychotherapy or similar interventions; (d) medical sleep problems (e.g., sleep apnea); (e) lack of mastery in hebrew.

Keywords: preschool children sleep problems nutrition problems online intervention psychological functioning
cholecalciferol and calcifediol are both useful to improve vitamin d serum levels

Conditions: Hypovitaminosis D

Summary: patients with hypovitaminosis d are randomized into three arms of treatment: group a: calcifediol 0,266mg each month group b: cholecalciferol 25000ui each 15 days group c: calcifediol 4 drops per day. serum levels of vitamin d are dosed after one month of treatment

patients with hypovitaminosis d are randomized into three arms of treatment: group a: calcifediol 0,266mg each month group b: cholecalciferol 25000ui each 15 days group c: calcifediol 4 drops per day. serum levels of vitamin d are dosed after one month of treatment to support the best dosage of vitamin d intake.

Eligibility criteria:
inclusion criteria: * hypovitaminosis d (\<20ng/ml) exclusion criteria: * osteoporosis (t score \<-2.5sd) * renal or hepatic diseases
mk0462 in treatment of migraine with recurrence (mk0462-022)

Conditions: Migraine Headache

Summary: a study to evaluate rizatriptan/mk0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo. the long term extension study which pools patients from mk0462-022, -025, and -029 is described in nct01286207.


Eligibility criteria:
inclusion criteria: * patient had at least a 6-month history of migraine, with or without aura * patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions * patient was judged to be in good health, apart from migraine exclusion criteria: * patient was pregnant or a nursing mother * patient had abused drugs or alcohol within 12 months prior to entering the study * patient had a history of cardiovascular disease * patient had clinically significant ecg abnormality * patient had a resting systolic blood pressure of greater than 145 mm hg or diastolic of less than 95 mm hg at screening * patient received treatment with an investigational device or compound within 30 days of the study start * patient typically suffered from less then 1 or more than 8 attacks of migraine per month * patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches * patient had prior exposure to rizatriptan
serratus plane block vs erector spinae plane block on postoperative analgesia in patients undergoing unilateral breast surgery

Conditions: Breast Cancer; Postoperative Pain

Summary: interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. in this study, we aimed to compare the effects of serratus plane block (spb) and erector spinae plane block (espb) on postoperative analgesia in patients undergoing unilateral breast surgery


Eligibility criteria:
inclusion criteria: * asa i-ii * age: 18 - 65 years * unilateral breast surgery exclusion criteria: * does not approve the study * pregnant * emergency * asa iii-iv * history of local anesthetic allergy * infection in the block area * coagulation disorder * morbid obesity (body mass index\> 40 kg / m²) * severe organ failure * previous neurological deficit * psychiatric disease * history of chronic pain

Keywords: serratus plane block, erector spinae plane block, postoperative analgesia
a pharmacokinetic (pk) trial in healthy asian and caucasian volunteers investigating the pk profile of eurartesim™

Conditions: Malaria, Falciparum

Summary: the study was designed to evaluate the pharmacokinetics of dha and pq in healthy volunteers and to assess the effect of ethnicity (asian vs caucasian), gender and body weight on the relative bioavailability of dha and pq.


Eligibility criteria:
inclusion criteria: * caucasian or asian healthy subjects, male or female, aged between 18 and 50 years (inclusive) * body mass index (bmi) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 36 kg. * agreed to use two approved methods of contraception * had given written informed consent to participate in this study in accordance with local regulations exclusion criteria: * had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing * pregnant or lactating (females only) * abnormal laboratory test results deemed clinically significant at screening * positive urine drug test or alcohol breath test * acute therapy for a serious infection within 30 days of study entry * history of significant drug allergies or significant allergic reactions * had participated in a clinical trial or had received an experimental therapy within 30 days or 10 half-lives of the drug * receipt of blood or blood products, or loss or donation of 450 ml or more of blood within 90 days before the first dose administration
corticosteroid/ropivacaine versus corticosteroid/saline injections for knee osteoarthritis

Conditions: Osteoarthritis

Summary: corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. however, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. despite this data, use of intra-articular anesthetic remains widespread. many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. however, there is no published data to validate this reasoning. therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. in light of this, the investigators question the routine use of anesthetics in joint injections. the purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. knee osteoarthritis (uni- or bilateral) as defined by the american college of rheumatology (staged by kellgren-lawrence radiographic grading scale) exclusion criteria: 1. rheumatologic/inflammatory disease 2. metabolic bone disease 3. crystalline arthropathy 4. current smoking 5. bmi \> 40 6. knee injection with corticosteroid or viscosupplementation within previous 6 months 7. history of knee prolotherapy, platelet rich plasma or cellular (stem cell) injection 8. knee surgery within the last year 9. chronic opioid use 10. chronic pain syndrome/fibromyalgia 11. pain behavior during the clinical encounter as judged by the injecting physician 12. physician specifically ordered injection of corticosteroid/anesthetic or other specific combined corticosteroid injection 13. diagnostic uncertainty by referring provider 14. referral for bilateral knee or multiple joint injections (\*note that arthritis involving multiple joints alone is not an exclusion criteria, only the patient receiving more than 1 injection)

Keywords: osteoarthritis injection steroid anesthetic
glp-1 effects on insulin and glucagon in ptdm

Conditions: Post-transplant Diabetes Mellitus

Summary: post-transplantation diabetes mellitus (ptdm) develops in 10-15 % of all renal transplant recipients within 10 weeks after transplantation, and has been associated with increased risk of cardiovascular disease and impaired patient survival. ptdm is primarily believed to be a variant of type 2 diabetes mellitus (t2dm), but the pathophysiology underlying the impaired glucose metabolism in renal transplant recipients with ptdm is unclear and some aspects are still poorly investigated. hyperglycemic clamp investigations with concomitant infusion of glucagon-like peptide-1 (glp-1) are warranted for a thorough characterization of the α-cell and β-cell function. the primary objective of the present study is to investigate whether hyperglucagonemia is present in renal transplant recipients with ptdm. furthermore, the investigators aim to examine the insulinotropic and glucagon suppressive effects of glp-1 (compared to placebo) in ptdm patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic clamp), respectively.


Eligibility criteria:
inclusion criteria: * renal transplant recipients more than 1 year post transplant with stable renal function (less than 20% deviation in serum creatinine within the last 2 months) and stable prednisolone dose (maximum 5 mg/day) the last three months before inclusion * diagnose of ptdm on standard clinical follow-up performed 8 weeks and 1 year post transplant at ous-rikshospitalet (fasting plasma glucose ≥ 7.0 mmol/l and/or 2-hour plasma glucose ≥ 11.1 mmol/l following an oral glucose tolerance test) or * non-diabetic renal transplant recipients with a normal glucose tolerance test (control group) * \> 18 years of age * bmi 18.5-29.9 kg/m2 * signed informed consent exclusion criteria: * severe liver disease * pancreatitis (chronic or acute), previous bowel resection, inflammatory bowel disease, malignancy (previous or actual) * estimated gfr \< 25 ml/min/1.73 m2 * pregnant or nursing mothers